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Proposed Framework for Evaluating the Safety of Dietary Supplements

Released:
April 3, 2003
Type:
Consensus Report
Topic(s):
Biomedical and Health Research, Diseases, Food and Nutrition, Public Health
Activity:
Framework for Evaluating the Safety of Dietary Supplements
Board(s):
Food and Nutrition Board

Use of dietary supplements has increased significantly over the past decade. While these products are presumed safe when used by consumers, the U.S. Food and Drug Administration (FDA) has no authority to require specific safety studies be done prior to the products' appearance on the market.  Current laws require that FDA prove a supplement is unsafe in order to remove it from the marketplace. 

At the request of FDA,  Food and Nutrition Board committee has proposed a scientifically based approach to be used by FDA for prioritizing and evaluating dietary supplement ingredients on the basis of available information on safety.  This approach is described in the report, Proposed Framework for Evaluating the Safety of Dietary Supplements, which is being released for public comment at an open meeting.
 


Other Reports by this Activity

  • Dietary Supplements: A Framework for Evaluating Safety Although vitamin and supplement manufacturers are restricted from claiming that using their products leads to therapeutic benefits, surveys show that many people take supplements for purposes such as treating colds or alleviating depression. According to other survey data, the majority of consumers believe these products to be either reasonably or completely safe. To bolster the FDA's ability to evaluate the safety of dietary supplements, the Institute of Medicine report Dietary Supplements: A Framework for Evaluating Safety outlines a science-based process for assessing supplement ingredients, even when data about a substance's safety in humans is scarce.
    Released: April 1, 2004

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